Access to Compounded Treatments
Since the 2013 passage of the Drug Quality and Security Act, the Academy has been working with ophthalmic subspecialty organizations to ensure continued access to the compounded and repackaged drug products on which our patients rely. Much of our advocacy effort has focused around continued access to biologics such as bevacizumab (Avastin), but the Academy also works to address other issues, including access to other compounded or repackaged drugs for office use.
Office Use
The Academy is working to compel the FDA to revisit its 2016 guidance that states only outsourcing facilities may compound non-patient specific drugs for hospitals, clinicians, and health care practitioners. We believe it is negatively impacting patient care. Under the guidance, traditional compounding pharmacies are barred from distributing compounded drugs without a patient-specific prescription. However, many ophthalmic drugs needed for office-use are not available through outsourcing facilities, which are allowed to compound drugs for office-use. The Academy, along with ophthalmic subspecialty organizations, have participated in numerous meetings with FDA officials to discuss issues pertaining to drug compounding and ophthalmology’s continued need for access to compounded and repackaged treatments for office-use.
In addition, we are supporting the Preserving Patient Access to Compounded Medications Act (H.R. 1959), introduced by Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas, in 2019. This bipartisan bill would let traditional compounding pharmacies distribute compounded drugs without a patient-specific prescription in states that allow office-use compounding.
Limited Availability of Avastin & Efforts to Address Increased Pricing
The Academy has been working to address and educate members about access issues to repackaged Avastin. In 2019, multiple outsourcing facilities faced shortages due to difficulty aligning with new federal standards. The Academy provided members with frequent updates about Avastin availability and pricing. More information can be found on the Academy’s website: https://www.aao.org/advocacy/avastin-shortage.
In response to the rising costs of obtaining repackaged Avastin, the Academy has been working with CMS and MACs to obtain increased reimbursement. As a result of Academy efforts, three Medicare Contractors, Noridian, WPS, and most recently First Coast, have increased payments to $94, $90, and $85, respectively. We continue to share new IRIS data on documenting significant reductions in market share/use of Avastin and updated pricing/costs for our practices to obtain fair payments for repackaged Avastin.
Protecting Access to Compounded Moxifloxacin
The Academy is working with the ophthalmic community to protect access to a compounded drug widely used to prevent post-cataract endophthalmitis. In July, the FDA proposed removing moxifloxacin hydrochloride from the list of bulk substances that certain outsourcing facilities may use to compound drugs for office use.
If the FDA approves this plan, ophthalmologists would have to use drugs compounded from other branded forms of moxifloxacin, which could result in shortages and quality and safety issues, as we noted in a recent group letter to the FDA. Rather than removing moxifloxacin from the bulk substances list, the ophthalmic community has urged the FDA to provide more information on a recent outbreak of toxic anterior segment syndrome (TASS) cases possibly linked to the drug.
If you are experiencing difficulty accessing repackaged biologics or other compounded drug products, share your experience with Scott Haber, manager, federal affairs and public health, in the Academy’s Washington, D.C. office at shaber@aao.org.